drugset / Trial / NCT03914755
A Safety, Tolerability, and Pharmacokinetic Study of Tucatinib in Healthy Japanese and Caucasian Subjects
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is being done to compare the pharmacokinetics (PK) and safety/tolerability of tucatinib in healthy Japanese and Caucasian participants. Three cohorts of healthy Japanese and Caucasian men and women will be admitted to the Clinical Research Unit (CRU) and receive multiple oral doses of tucatinib over 14 days with and without food. Subjects will be in the study for up to 45 days, including the screening period. Due to practical considerations, each cohort will be dosed sequentially (this is not a dose escalation study).
Timeline
- Start
- 2019-05-08
- Primary completion
- 2019-08-04
- Completion
- 2019-08-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tucatinib | Small molecule | 50 mg | Oral |
| Subject | Tucatinib | Small molecule | 150 mg | Oral |
| Subject | Tucatinib | Small molecule | 300 mg | Oral |
Indications
No indication recorded.